US FDA reveals new higher PDUFA fees for 2026

31 July 2025

The US Food and Drug Administration has set prescription drug user fee rates for fiscal year 2026, with increases across all key categories under the Prescription Drug User Fee Act (PDUFA) VII.

The application fee for submissions requiring clinical data will rise to $4.68 million, compared with $4.31 million in fiscal 2025. Applications not requiring clinical data will carry a fee of $2.34 million, up from $2.16 million, while the annual program fee for marketed products will increase to $442,213 from $403,889.

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